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NCT Number: NCT02879942

First Trimester Placental Assessment in the Screening of Preeclampsia and Intrauterine Growth Restriction

Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.

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Key information

Conditions

Preeclampsia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Hypertension, Pregnancy-Induced Intrauterine Growth Restriction Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

11 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnancies with fetuses with CRL between 45 and 80mm
  • absence of chromosomal abnormalities
  • absence of congenital anomalies
  • absence of congenital infections

Exclusion criteria

  • patient not accepting to participate in the study
  • multiple pregnancies
  • pregnancies without ultrasonographic confirmation of gestational age

Treatment and study plan

Ultrasound study of the placenta

Other

The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.

Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test

Other

Primary outcomes

  1. Development of preeclampsia

    Time frame: Up to birth

    Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection

  2. Development of intrauterine growth restriction

    Time frame: At birth

    Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2016
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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